Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

返回 Agenda

Featured Oral Abstract: Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov

Session Chair(s)

Issis J Kelly Pumarol, MD

Research Subject Advocate

Wake Forest Baptist Health, United States

Changes, including new results reporting rules and NIH policy on clinical trials registration, present compliance challenges for investigators and institutions. We performed a compliance review revealing the need for institutional awareness of these requirements, how to navigate the ClinicalTrials.gov system, and hands-on support for study teams in managing the records. This central approach of monitoring, education, and support could be replicated at any institution. By providing investigators with resources to comply with regulations and ethical obligations, we hope to facilitate research.

Learning Objective :
Apply the use of systems currently in place to obtain and maintain compliance with ClinicalTrials.gov requirements
Evaluate the current status of your organization/department compliance with ClinicalTrials.gov regulations
Predict what level of risk your organization will have in relation with the number of trials in the database and FTE’s maintaining an institutional account